Method and a system for assisting a user in a medical self treatment, said self treatment comprising a plurality of actions

ABSTRACT

This invention relates to a method of assisting a user in a medical self treatment, said self treatment comprising a plurality of actions, said method comprising the steps of collecting in a one or more databases data representing values of parameters relevant for said self treatment, and the step of processing said one or more databases to provide for alternative choices between two or more action and a corresponding value for each two or more actions. The invention also relates to a computer system having means for performing the method according to the invention, and a computer readable medium having a program recorded thereon, where the program when executed is to make the computer execute the method according to the invention

The present invention relates to a method of assisting a user in amedical self treatment, said self treatment comprising a plurality ofactions.

The present invention also relates to a system/an apparatus forassisting a user in a medical self treatment, said self treatmentcomprising a plurality of actions.

In the following a user/patient will be a patient having diabetes.

For a number of years it has been possible to purchase various devicesfor the treatment of diabetes, e.g. for injecting insulin, for measuringblood sugar (such a device is referred to as BGM in the following), forwithdrawing blood samples, and other accessories, the purpose of whichis to enable the patient to nurse his disease discretely and with a highstandard of safety.

Many diabetic patients are elderly people who can easily get insecurewith respect to the medical equipment. It is very reassuring andtherefore also very important that the user can have feedback from thesystem which confirms to the user that everything is OK right from thetechnical function of the system to the patient's physiologicalcondition. This stretches out a psychological safety net under thepatient, which contributes to improving the quality of life of patientshaving a disease such as diabetes.

Traditionally, diabetic people live under strict rules of “do's anddon'ts”. There is a historical need in order to comply with atherapeutic regimen. The purpose of this being a well controlled bloodglucose level (BGL) and thereby a much lesser risk of latercomplications. This is a highly undesirably situation from a‘quality-of-life’ point of view. It often results in bad mood—which isknown to lead to a poor BGL regulation. Thus an evil circle is createdwhich is hard for the diabetic to break.

Additionally, in certain cultures/societies there is a reluctanceagainst using syringes/needles to administer medication and peopletherefore choose alternative ways to try to comply with a regimen.However, this often has the unfortunate result that people choosealternatives that do not fully or at all correspond to the optimalregimen and thereby choose wrong alternatives with adverse effects.

Further, the metabolism is a very complex and dynamic system. It is veryhard to get and maintain an overview for the diabetic as many factorsplay a role. It is very likely that the diabetic looses an overview orrelies on too simple rules of operation or eventually neglect theillness.

Various systems trying to ease the hazels of diabetes have been proposedover time. These systems have basically an accounting role and simplykeep track of whatever input the user specifies. In these systems inputof food and exercise are usually a task that the user needs to initiate.Systems that rely on the user to take action can be hard to makefunction well due to the user's reluctance to deal with it.

Patent specification WO 95/32480 discloses a medical informationreporting system which has a patient sensor device controlled via apatient operated interface device by a micro-controller which writesdata to a memory and a report writer. The specification furtherdiscloses a warning algorithm with zone boundary values which isspecified by the user and consent to by a physician. This system simplykeep track of whatever input the user specifies.

Patent specification WO 94/24929 discloses a patient support andmonitoring system, which has a database located at a remote location forcollection of information in a remote database from sensors and amedicine administration system. This system also keep track of whateverinput the user specifies and may initiate a medical reaction on thebasis of received parameters.

The object of the invention is to provide a method which provides a userwith a freedom of operation with respect to a self-treatment.

This is achieved by guiding the user with respect to a self treatment bypresenting options/possibilities in such a way that compliance to aregimen may be obtained in numerous ways.

More particularly, the invention relates to a method of assisting a userin a medical self treatment, said self treatment comprising a pluralityof actions, said method comprising the steps of

-   -   collecting in a one or more databases data representing values        of parameters relevant for said self treatment, where said        method further comprises the step of    -   processing said one or more databases to provide the patient        with!! SaaS' forslag!! alternative choices between two or more        actions and a corresponding dose for each two or more actions.

Hereby, the user's self-treatments change from restrictions topossibilities thereby enhancing the overall ‘quality-of-life’ for theuser and better ensuring that the user's self-treatment complies betteror fully with a specified regimen by choosing proposed choices whichcomplies with the regimen. This avoids that the user chooses actions andalternatives which do not fully or at all correspond to the optimalregimen due to a lack of a clear overview of the complex factorsinvolved in the self-treatment.

By providing the user with a number of options he may choose the one(s)he likes best and still obtain the right and full treatment instead ofchoosing the easiest and most appealing course of action on his own,which may be wrong or insufficient and result in adverse effects.

Additionally, the possibility of choices fulfilling a prescribed regimenmakes the patient feel more in control of the treatment and enhances thetherapeutic value of the treatment and improves the patient's ability toadapt his treatment to his daily life.

Additionally, the user's feeling of being ill is reduced, since the userhas options of choices instead of a dictation of actions.

An additional object of the invention is to estimate one or more futurevalues for one of said parameters, in order to obtain information of theuser's condition in the near future, hereby enhancing the possibilitiesof presenting better/more relevant choices.

One way of estimating one or more future values may be done on the basison a dynamic model representing the human metabolism.

An additional object of the invention is to provide effective monitoringof electronic data/information which are used by a patient forself-treatment of a disease, so that a greater level of safety, bothfunctionally and emotionally, and an effective feedback to the patientare obtained.

The invention also relates to computer system having means for executinga program, where the program when executed is to make the computerexecute the method according to claims 1-19.

By computer system is meant a system comprising processing means andbeing programmable at one time or another in order to execute a set ofinstructions/commands like a system for the self-treatment of a patiente.g. comprising one or more of sensor, medication administering device,data collection, and displaying means or a general computer system as aPC, laptop, palmtop, or a system having at least one device comprising amicro controller adapted to execute a program (either in hard- and/orsoftware), and so on.

The invention further relates to a computer readable medium having aprogram recorded thereon, where the program when executed is to make thecomputer execute the method according to claims 1-19.

The computer readable medium may e.g. be a CD-ROM, magnetic disk, ROMcircuit, a network connection or generally any medium that may provide acomputer system with information of how to executeinstructions/commands.

The above mentioned system and method need as good as possible datacollection in order to present relevant and useful choices/proposals tothe user. In a preferred embodiment a system/method relating toindividual apparatuses, which are provided with electroniccommunications equipment so that the apparatuses—when in a state ofmutual communication—frequently exchange information between them, areprovided. Hereby a greater functional safety can be achieved and thetotal data capacity of the system can be increased, so that the feedbackpossibilities, e.g. of the system checking that every apparatus is OKand set up properly and of the patient be given a number of possible andup to date choices to choose from in a given situation, are increased.

The individual devices may be arranged for various respective functionsrelevant to the treatment of e.g. diabetes, such as: a lancet device, abody fluid analyser, one or more drug administration apparatuses foradministering a predetermined dose of medication to the patient.Further, there may be a number of other aids which the diabetic patientuses, e.g. test strips for the blood analyser, needles, napkins forwiping off blood, extra insulin cartridge, glucose tablets, wastecontainers, etc.

The apparatuses according to the example may communicate informationsuch as: amount of medication, type of medication, the concentration ofrelevant substances in the body e.g. body fluid level/concentration,time stamp, amount of food (e.g. amount or units of carbohydrate),measurement of physical activity, notification (e.g. alert and warning)to the patient, body characteristics (e.g. weight, blood pressure etc.)and inventory logistics. This ensures that relevant information, fore.g. a drug administration system like a doser, i.e. number of units ofinsulin, insulin type and time and date for administering, canautomatically be stored, displayed, received and transmitted to and fromall the relevant apparatuses and more particularly in one or moredatabase accessible by a system/method for processing in order to obtainthe results described above and later. The doser could also receiveinformation regarding a predetermined number of units of insulin to beadministered and automatically set the amount of medication to beadministered by electromechanical means. In this way elderly andhandicapped people do not have to set the relevant amount of medicationthemselves but just activate the doser and a confirmation of the actualadministered dose may be used as input.

Other types of drug administration systems like an inhaler adapted toadminister a dose of medication in an air stream or a tablet dispensermay be included instead or in combination with the doser. The inhalerand/or tablet dispenser may also communicate with the other units forrelevant information like the doser according to the invention.

It is especially useful to transmit the data from all apparatuses to thefunctional master module/apparatus containing the highest priorityprogram for safe keeping, calibration and updating of data and possibletransmission to e.g. an external unit like a PC or database for furtherdata acquisition, storage and processing. In this way the patient, aphysician or an expert care-team can obtain the behavior over time ofthe patient, and a check for compliance to a diet or treatment given tothe patient by a physician or an expert care-team can be made. Thisenhances the possibility of choices according to the invention.

Additionally, it is also possible for the patient to manually inputinformation about the treatment. This information may be historicinformation as well as information about a future scheme (behavioralpattern) e.g. planned physical exercise, administering of insulin,intake of food and other medications. This information may be collectedand thus serve as an electronic diabetes diary or may be used to notifythe patient through the receiving means as to whether the plannedactions are dangerous or not. The patient can further receiverecommended amounts of medication, exercise, food, etc. from aphysician, from an expert-team or automatically. All this informationmay be used to estimate one or more future parameter values, e.g. BGL.

It is evident that since the apparatuses are to be carried by thepatient, there is a potential lack of space for an advanced input devicee.g. a keyboard.

Therefore, information which cannot be input on a standardized form e.g.personal comments on the treatment may be typed into the apparatus bythe patient using a simple input device once and can subsequently bechosen from a list, if needed again.

Preferably, all the apparatuses of the system exchange information sothat every apparatus (or at least every apparatus within range) isupdated with the combined information, but still one particularapparatus is the link to any outside systems, so that every bit ofinformation is mirrored for better safety and backup. This demands agreater amount of total memory capacity for the system.

For a BGM according to an embodiment of the invention the relevantinformation could be the time and date for measurement, measuredlevel/concentration of blood glucose which could be stored ortransmitted to another apparatus.

For a doser according to an embodiment of the invention the relevantinformation could be the type of medication (e.g. long acting or shortacting insulin), number of units of insulin to be administered and thetime and date of the administering. This information could both be setmanually by the patient or remotely by a physician, an expert care-teamor automatically.

For an inhaler according to an embodiment of the invention the relevantinformation could be the type of medication, the number of units ofmedication to be administered and the time and date of theadministering. This information could both be set manually by thepatient or remotely by a physician, an expert care-team orautomatically.

For a storage container according to an embodiment of the invention therelevant information could be used to keep track of the contents of thecontainer so that every time an object (e.g. cartridge, needle, etc.) isused, the storage container will update the inventory list. This listcould be transferred to a unit of highest priority immediately or later,which could in turn update the patient's total holdings of objects, sothat the system could notify the patient when he should order a newstock of objects in order to keep all the different proposed actionsavailable. The ordering could also be done automatically by the systemif the inventory list is transferred to an external unit, which greatlyimproves the confidence, comfort and safety of the patient.

For a tablet dispenser according to an embodiment of the invention therelevant information could be the number of dispensed tablets, thenumber of remaining tablets, the time of dispension and the type ofdispensed tablets. The dispenser could store and/or communicate thisinformation to an available unit of highest priority or other unitswithin communication range.

In the following a preferred embodiment according to the invention isdescribed in detail. This particular embodiment is meant as one exampleonly of the invention and should not as such limit the scope ofprotection as claimed in the appended claims.

The term “Margin Maker” is used in the following for a method/systemaccording to the invention.

The invention will now be explained in detail with reference to theFIGS. 1-8, in which

FIG. 1 shows a flowchart for an embodiment of the invention illustratingan exemplary implementation of a Margin Maker system;

FIGS. 2 a, 2 b and 2 c show examples of user interfaces presenting andreceiving choices to and from a user;

FIG. 3 illustrates a schematic diagram of an exemplary expert systemusing a model;

FIG. 4 shows a more detailed representation of a time dependent dynamicpatient model according to the invention;

FIG. 5 shows an example of a preferred system which may contain anembodiment according to the invention;

FIG. 6 shows another embodiment according to the invention;

FIG. 7 illustrates the general concept according to an embodiment of theinvention with respect to communication and exchange of information;

FIG. 8 illustrates the communication between a system of apparatuses anda central system.

FIG. 1 shows a flowchart for an embodiment of the invention illustratingan exemplary implementation of a Margin Maker system.

In step 101 input data is provided/updated. More specifically differenttypes of input data are updated as represented by the steps 102-105.

In step 102 data from a care-team is provided/updated. This datadescribes individual user/patient characteristics which are true/validin the time interval between consultations with the care-team. The datais typically derived as a result of tests performed by health careprofessionals (e.g. insulin sensitivity) and entered into the system bythe care-team, e.g. wireless via a mobile telephone system as describedin connection with FIG. 8.

In step 103 treatment input data is provided from various devices, e.g.from a system of portable apparatus as described above and in connectionwith FIGS. 5-7.

Input data specified manually by a user may also be input in step 103.Manually specified input data may e.g. be a value representing the bodytemperature of the user e.g. because he is feverish. Manually specifiedinput may preferably if it differs from his normal value.

This data describes the actual treatment received by the patient (e.g.insulin intake as a function of time) and the resulting effect on theuser (e.g. blood glucose level as a function of time). The data isgathered by the various devices used by the patient in hishome-treatment and communicated automatically to the Margin Maker.

In step 104 the previous choices, i.e. input from the user, areprovided/updated.

This is a record of the previous activities which the user has chosen toperform and which are either not yet confirmed by other input means(e.g. insulin injection prior to synchronization between the insulindoser an the Margin Maker) or not confirmable by other input means (e.g.physical exercise or food intake).

In step 105 information of time is provided from a system clock in theform of a time stamp. Additionally the date may be specified as well.

It is necessary for the method to know the time because the alternativeproposals available to the user change over time.

The information provided/updated in the steps 102-105 is collected in adatabase as a dataset at step 106.

Prior to processing the input data the system performs a test at step107 to find out if the amount and/or quality of the input information issufficient to produce valid and relevant proposals for user behaviour topresent for the user of the Margin Maker system.

If the test fails, i.e. the input data is insufficient to produce arelevant output, the user is made aware of the fact that at the momentthe Margin Maker is unable to offer guidance due to lack of inputinformation and displays a request for more (comprehensive) data andissues a warning at step 108.

If the test is successful, the method continues in step 109, where theprovided/inputted data is processed in an expert system e.g. using amodel.

The expert system is in principle a model of a control loop for theblood glucose level in a human. Based on the input and the historicaldata accumulated in the Margin Maker the parameters of the model isadapted to mimic and predict the blood glucose control of the individualuser of the Margin Maker system. Refer to FIGS. 3 and 4 for a moredetailed description of the expert system.

For each of the n possible user actions implemented in the Margin Makersystem the model is fed with information of the present blood glucoselevel, the target blood glucose level, the current time, the n−1 useractions set to their present value (ceteris paribus), and 1 user actionis treated as a variable parameter. After n recalculations of thecontrol loop, one for each of the n possible user actions treated as thevariable parameter, the expert system has derived n ways of bringing thepresent blood glucose level to its target value. Then an evaluation ofthe n alternative proposals is needed in order to exclude proposals thatare not implementable (e.g. it is not possible to eat a negative amountof food), thereby providing the ‘up to n’ valid and implementableproposals of possible choices 110.

In general, the sooner proposals are chosen, i.e. a is situation isacted upon, the more options/proposals is available to the user. Put inanother way, as the time goes the proposals/options become fewer andfewer as well as more and more restrictive, since the user's situationgets more and more serious, i.e. drifts away from a normal BGL, if notpaid attention to/acted upon.

Another criteria for exclusion of proposals may e.g. be in a system, asdescribed above, comprising different portable/handheld devices that thespecific device being used to implement the proposal is present andactivated among a user selected group of the devices. In this way theuser will only be presented with proposals that he actually has thepossibility of executing.

Finally, the time is considered variable in the expert system—otherthings being equal—to test whether a potentially dangerous situation isexpected to occur within a given time frame. If this is found to be thecase, a warning flag is set in step 111.

In step 112 a test whether the warning flag has been set is executed. Ifthe test is true/yes (i.e. the warning flag has been set) a warningsignal is sent to the user in step 113, regardless of whether the useris accessing the system, e.g. by audio to attract the user's attentionand/or by activation of the display containing appropriate information.After the signal is given the method continues in step 115 where thewarning and proposals are presented as will be described later.

If the test in step 112 results in false/no, another test is executed instep 114 as to whether the system is accessed by the user. If this isnot the case, the method continues from the beginning in step 101 andawaits new and/or updated input since the present situation does notspecifically require the attention of the user (warning flag not set).

If the test in step 114 is true and the user is accessing/has activatedthe system, step 115 is executed.

In step 115 the valid and implementable proposals are presented to theuser. Any warnings are also displayed to the user if the preceding stepwas step 113 in order to alert the user and obtain an immediate actionfrom the user. Issued warnings could e.g. comprise information that theuser should seek medical attendance or administer a given medication asquickly as possible, etc.

The proposals may e.g. be presented in the form shown in FIGS. 2 a, 2 band 2 c or other suitable forms.

In step 116 the system awaits a user choice of one of the proposedactions or a time out from the system.

Each of the proposals presented to the user of the Margin Maker willbring his/her blood glucose level “back on track” but that does not inany way exclude the possibility that the user chooses only to partlyfollow a suggested proposal, e.g. administering half the dose ofmedication instead of the proposed dosage, or to combine severalproposals fully or in part. Once the user has entered his/her choice theMargin Maker performs a rerun of the flowchart to update the relevantproposals, given the new situation. An example of proposals and selectedchoices is shown in FIG. 2 a.

If the user chooses to do nothing, the system will eventually issue atime out and perform a rerun of the flowchart to update the relevantproposals taking into account that time has elapsed since the last useraction.

Hereby a user is presented with a number of choices each fulfilling aregimen where he may choose the one(s) he likes best and still obtainthe right and full treatment instead of choosing the easiest and mostappealing course of action on his own, which may be wrong orinsufficient and result in adverse effects.

Additionally, the possibility of choices makes the patient feel more incontrol of the treatment and enhances the therapeutic value of thetreatment and improves the patient's ability to adapt his treatment tohis daily life.

FIGS. 2 a, 2 b and 2 c show examples of user interfaces presenting andreceiving choices to and from a user.

FIG. 2 a shows an example of a user interface where one column 201comprises different graphical icons 205-210 each representing one choiceof action according to a proposal. Shown in this example are icons205-210 for administering fast acting insulin 205, administering slowacting insulin 206, administering tablets of a given type 207, exercise208, intake of food 209, and intake of alcohol 210. Additionally, othericons like administering tablets of another kind, administering a dosagemedication from an inhaler, etc. may be presented if these options areavailable to the user.

At column 202 the n proposals suggested by Margin Maker are shown(corresponds to step 115 in FIG. 1), where each proposal of action, ifexecuted, brings the current BGL to the target BGL. In this example theMargin Maker has proposed to the user/patient either to administer 10units (IU) of fast acting insulin, administer 0 IU of slow actinginsulin, administer two tablets of a given type, exercise for 60minutes, intake 0 units of food, or drink 0 units of alcohol.

At column 203 the user input is shown. After he has input the choice andamount of action, the Margin Maker displays and derives updatedproposals on the basis of the changed situation. Here the user haschosen to administer 5 IU of fast acting insulin, and the Margin Makernow presents the updated proposals at column 202′, given the newsituation and taking into account the user's choice.

The updated proposals at column 202′ are now to administer additionally5 IU of fast acting insulin, administer 0 IU of slow acting insulin,administer one tablet of a given type, exercise for 30 minutes, intake 0units of food, or drink 0 units of alcohol.

The user now chooses to exercise 30 minutes, which is shown at column203′, and the model updates the proposals accordingly. The proposalsshown at column 202″ show that after the user has performed thespecified choices/actions his BGL should be at the target level.

The columns 204 represent previous and later proposals and user input,so it is possible to scroll through the values for different points intime.

This specific form of user interface requires a display of a certainquality or with a certain resolution. Other more simple forms may beprovided, e.g. as shown in FIG. 2 c, either instead or in combination indevices with a smaller display.

Alternatively, the display will only display one column of icons 201,proposals 202 and user input 203 at a time, e.g. with buttons to scrollthrough previous proposals and input.

The user may input data in many different ways according to specificembodiments of the invention as generally known in the art, e.g.utilising a touch screen with a stylus, touch pad and a cursor on thedisplay, etc.

It is evident that if the apparatuses are to be carried by the patient,there is a potential lack of space for an advanced input device e.g. akeyboard. Therefore, information which cannot be input on a standardizedform e.g. personal comments on the treatment is typed into the apparatusby the patient using a simple input device once and can subsequently bechosen from a list, if needed again.

Preferably, a system comprising a plurality of portable devices withmutual data communication, as described above, is used in connectionwith the Margin Maker.

In this way e.g. a doser may communicate an administered dose to thedevice containing the Margin Maker automatically or by user request andthe different devices may communicate measured values representingphysiological parameters automatically or by user request, e.g. a BGMmay communicate the measured BGL as input to the Margin Maker.

Additionally, information of which devices are present and activated maybe transmitted to the device containing the Margin Maker which mayhereby only present proposals with a corresponding present and/oractivated device, so that e.g. if a doser containing slow acting insulinis not available to the user, then the icon 206 and the correspondingproposal will not be displayed at all.

In FIG. 2 b an example of a user interface is shown where input ofinformation is given to the Margin Maker which is needed in order toderive the proposals of actions. Shown is a column 220 containing icons224 representing a value obtained from the BGM and 225 representing avalue for the temperature of the user. The corresponding values,specified at a given time, are listed in a column 221 and are in thisexample 10.5 mmol/l and 37.5° for the BGM and the temperature,respectively. The other columns 222 represents values specified atdifferent points in time where in this example no values are specified.Alternatively, only columns having a specified value are shown in theuser interface e.g. with a corresponding time stamp.

The columns 223 represent previous and later user input, so it ispossible to scroll through the values for different points in time.

This information is used by the Margin Maker together with additionalinformation to better estimate the target glucose level and obtain ameasure of the present glucose level. The input temperature is used bythe expert system to determine whether the user is feverish or not asthis influences the required amount of insulin.

This information may either be input manually by the user, automaticallyor both, e.g. by a BGM device and/or a temperature sensor withcommunication means which may communicate with a Margin Maker device(may correspond to step 103 in FIG. 1).

FIG. 2 c shows an example of a different user interface which may bemore suited for a smaller display. Shown is an example of a graph 230with a time axis 231 and three BGL bars 232 and 232′ obtained at threedifferent points in time of the day. Two previously obtained BGLs 232and one BGL 232′ obtained at the actual time. The BGL may be obtainedfrom a BGM and may be received either automatically or manually by theMargin Maker as input for the expert system as described above.

Also shown are two bars 233 representing the dose of insulin, that theuser chose to administer previously after obtaining the BGLs 232,respectively. The dosages 233 may have been fully or partly as proposedby the Margin Maker at the respective time. Alternatively, the user mayhave administered the dosages 233 completely on his own and justspecified the dosage and type of medication. The actual dosages 233administered may have been specified (together with the time and type ofinsulin) by user input or via communication from the administering doserto a device containing the Margin Maker.

The previously obtained BGLs 232 and administered dosages 233 togetherwith the BGL 232′, obtained at the actual time and other relevant input,as described in connection with FIG. 1, and used to predict a futurecourse of BGL for the user and derive one or more proposals to the userin order to account for the future course of BGL.

The Margin Maker has proposed in this example that the user shouldadminister a dosage as indicated by the blinking bar 233′. Additionally,other proposals may be shown elsewhere. The proposed dosage and type ofinsulin may be transmitted automatically to a corresponding doser, so ifthe user wishes to follow this proposal fully he just has to activate abutton on the doser to accurately receive the proposed dosage.Alternatively, the user may manually specify the proposed dosage on thedoser.

Additionally, the user may choose to only administer a part of theproposed dosage (which may also be transmitted automatically afterindication by the user) if he e.g. wants to exercise as well. After theMargin Maker has registered the user's choice of only administering apart of the proposed dosage of medication, the expert system is updatedaccordingly and new proposals are derived taking into account the newsituation.

The user interfaces described in connection with FIGS. 2 a, 2 b and 2 care just examples and other interfaces may be just as applicable.Alternatively, the user interface may be character based and using nographics thereby reducing the complexity of the system with respect toimplementation.

FIG. 3 illustrates a schematic diagram of an exemplary expert systemusing a model.

A number of models have been proposed in order to describe themetabolism of the insulin dependent diabetic patient. Furthermore, someeffort has been put into constructing systems for controlling the bloodglucose level using insulin.

In the following one expert system is described as an example but otherexpert systems known in the prior art may be used with similar results.The shown expert system comprises input variables 301 and 302,physiological parameters and model inputs 306, proposal generators 305,patient actions 304, and a patient model 303, all of which will bedescribed in the following.

An input variable “Desired blood glucose level” 301 is specified in theexpert system and is preferably (pre)determined by the care-team orother professionals. The variable 301 may be similar to the bloodglucose level of a healthy person, but may due to regimen differ fromthis value, e.g. be higher in order to prevent hypoglycaemia.

Another input variable used by the expert system is the variable “Bloodglucose measurement” 302 representing the BGL at a given time.

The patient may measure the BGL, giving the blood glucose measurementvariable 302, with a certain frequency or use a continuous blood glucosesensor. Given the dynamics of the human metabolism, there is a certainlower limit of the sample frequency which will allow the expert systemto work properly.

The patient model 303 is a dynamic model which describes the metabolismof the diabetic patient. The model 303 incorporates parameters 306 suchas e.g. weight of the patient and insulin sensitivity, which vary frompatient to patient and may be considered constant between consultationsof the care-team. The model 303 may also incorporate model input 306such as injections of long acting insulin, fast acting insulin, oraldiabetic agents, exercise, food intake, alcohol intake and fever. Givena certain combination of model input 306, the model 303 describes theblood glucose level over time. The model 303 describes some key statevariables of the human metabolism.

The proposal generators 305 are the analogy of regulators in a controlsystem. The input to the proposal generators 305 is the differencebetween the desired blood glucose level 301 and the actual blood glucoselevel 302 and the state variables of the patient model. Given the inputeach proposal generator 305 proposes a patient action and acorresponding amount/dosage—eat a certain amount of food, exercise for acertain amount of time, inject a certain amount of fast acting insulin,etc.—as indicated in the proposal boxes 305. The proposals arecalculated, presuming that only one of the proposals is followed.

The patient has the final decision as indicated by patient action 304for each possible action in the expert system. He may or may not chooseto follow the proposals. By choosing one of the proposals fully orpartly, his action 304 is fed into the patient model, either by manualinput or automatically by the diabetes specific devices—the dosers orthe blood glucose monitor. The patient model 303 now generates a newinput to the proposal generators 305 which represents the updatedsituation.

FIG. 4 shows a more detailed representation of a time dependent dynamicpatient model according to the invention. This model is used by theexpert system to give a prediction/estimate of a future BGL.

In the literature many such models are described. Here a very simple oneof applicant's origin is taken to explain the principles. This model canbe developed to a high degree of detail, if needed.

The model 400 simulates the dynamics of the carbohydrate metabolism.Based on the input of one or more of the following parameters

-   -   BGL,    -   dosage of medication,    -   type of medication,    -   food intake,    -   drinks intake,    -   exercise,    -   time stamp,    -   insulin sensitivity    -   weight of the user,    -   blood pressure,    -   temperature, and    -   other.

The model is tuned in to mimic the user's carbohydrate metabolismclosely. By the continuous tuning by input of updated data from theexpert system a drift away from a close mimic of the true status isprevented. The structure of the model 400 matches the functionalities ofthe metabolism to a needed degree. Due to this correspondence the expertsystem/model 400 will be able to predict trends or even future BGL.

The expert system continuously gives suggestions about the user'sfreedom of operation. Based on all recorded events a margin for exerciseand food is suggested.

If suggestions are confirmed (e.g. tapping an indication on the touchscreen of the handheld device), these are regarded as input to thealgorithm and used for future suggestions.

Preferably, the dialogue is implemented via a graphic display showingthe history, and input is given either via a touch screen or traditionalbuttons.

In order for the expert system to give recommendations and margins asdescribed above it is needed to predict how things will evolve from anyknown state.

This can be done using a model 400 of the carbohydrate metabolism as anengine for the Margin Maker concept.

Shown in the figure is a model 400 with two pools: Body Blood Glucose402 and Insulin 401. Each has a filling source 403, 403′ and a drain404, 404′ (i.e. two rates), respectively. Body Blood Glucose 402 has thefilling source POG (Production of Glucose) 403 and the drain UOG (Use ofGlucose) 404, and Insulin 401 has the filling source POI (Production ofInsulin) 403′ and the drain UOI (Use of Insulin) where all the rates403, 403′, 404 and 404′ may vary with time dependent on the parameterscontrolling the rates.

The parameters controlling the rates, e.g. food, dosing, exercise, etc.,are given in the table below.

The model 400 can also be expressed in terms of a set of differentialequations for the states 402 and 401, each being controlled by theirrespective rates 403, 404 for the state Body Blood Glucose 402 and 403′and 4041 for the state Insulin 401. In this form the model can beimplemented in a microprocessor relatively easily and display theresults of the latest input for any given time.

The differential equations for the model 400 may be expressed as:BBG(t)=BBG(t−dt)+(POG−UOG)*dt

-   -   INFLOWS: POG=f(F,t)    -   OUTFLOWS: UOG=g(BM+KD+IIUOG+E,t)        I(t)=I(t−dt)+(POI−UOI)*dt    -   INFLOWS: POI=h(MPI,t)    -   OUTFLOWS: UOI=j(HL,t)

The factors are explained in the table below: Factor Explanation UnitFunction Input/Output D Dosing IU Output to the user about possibleinsulin doses to take. Alternatively the user can give input about awanted amount of insulin and the system can suggest appropriate foodintake. Whenever an insulin dose is taken the system automatically loadsthe value into the model and the predictions are calculated accordingly.E Exercise mol Output to the user about possible exercise to take in thegiven situation. Alternatively the user can give input about a wantedamount exercise and the system can suggest appropriate food intake. Theuser accepting the suggestion will be an input to the system andcalculation will be accordingly. Conversion to mol will be made by thesystem. F Food intake mol Output to the user about possible food to takein the given situation. The user accepting the suggestion will work asan input to the system and calculation will be accordingly.Alternatively the user can give input about a wanted amount of food andthe system can suggest either dosing of insulin or exercise. Conversionto mol will be made by the system. Concentrations and levels BBG BodyBlood mol Simulated total amount of glucose in the blood. Glucose It iscalculated as the integration over time of production and usage ofglucose. Between measurements it is used to give an estimate of theuser's current BGL. At measurements the BBG is updated according to themeasured BGL. BGL Blood mol/l This calculated by dividing the BBG withthe Glucose blood volume. Level The model has the ability to predict theBGL over time and the value is very important to the user and can bedisplayed at any time. Every time the user makes a measurement of theactual BGL this is automatically loaded into the model by the system andit overrules the calculated one and resets the model. Initial value: 5mmol/l I Insulin mol Insulin level in the body. The model has theability to predict the Insulin level over time. It is calculated as theintegration over time of production and usage of insulin. The initialvalue is set by the physician according to measurements and can becalibrated by the physician when the user meets for consultations. RatesPOG Production mol/min This rate is driven by the food intake enteredand Of Glucose accepted by the user. It is also a function of time asdifferent types of food have different dynamic impact on BGL. POIProduction mol/min This rate is driven by the injected insulin throughOf Insulin a conversion factor (MPI). It is also a function of time asdifferent types of insulin have different dynamic impacts on BGL. UOIUse Of mol/min This rate is defined by the half life (IHL) of insulinInsulin by which the level decays exponentially. UOG Use Of mol/min Thisrate is driven by 4 factors: Basal Metabolism Glucose (BM), KidneyDiurese (KD), Insulin Induced Use Of Glucose (IIUOG), Exercise (E).Constants & Transfer functions BM Basal mol/min Constant for eachIndividual determined by the Metabolism e physician. Typical value: 0.56mol/min IHL Insulin Half min The metabolism of insulin is usuallyexpressed in Life terms of half life. Typical value: 10 min IIUOGInsulin mol/min This factor describes the nonlinear relation Inducedbetween insulin in the body and the Use Of disappearance of glucose fromthe blood. This Glucose factor can be measured or derived fromliterature. KD Kidney mol/min This factor describes the nonlinearrelation Diurese between diurese and BGL. At BGL levels below 10 mmol/lthe KD is virtually zero. Above 10 mmol/l an increasing KD will occurMPI Mol Per IU mol/IU Conversion factor between International Units ofinsulin and mol

This model 400 is just one relatively simple example of a model that maybe used to predict a future BGL.

Alternatively, the model and/expert system or parts hereof may belocated in a stationary unit with greater computational power andreceive input and transmit information regarding proposed choices.

FIG. 5 shows an example of a system which may contain an embodimentaccording to the invention.

Shown is a doser 20 with a cap 10 where the cap 10, in an embodiment,functions as the functional master module. In the preferred embodimentthe Margin Maker resides in the functional master module. The functionalmaster module 10 has displaying means 11 and buttons 36 for operationand selection of proposed choices.

The doser 20 is a conventional doser with has transmitting and receivingmeans 12. This enables the doser 20 to transmit stored data, i.e. thetime, date, is amount and type of medication, to the functional mastermodule 10 for storage and presentation there via the master modulesreceiving means 12. Additionally, the transmitted data may be input tothe Margin Maker automatically, thereby updating the model and derivingand presenting new proposals/choices, reflecting the updated situation,to the user on the display 11.

The doser 20 can also receive information via the receiving means 12from the master module 10. This information could for instance be apredetermined amount of medication as dictated by a proposal from theMargin Maker if the user chooses to administer the full amount given bythe proposal. The received information is then used to automatically setthe correct amount of medication to be administered so that the patientdoes not have to worry about that aspect. Alternatively, if the useronly wishes to administer only a part of the proposed dosage, he mayindicate this via the buttons 36 or directly on the doser 20, afterwhich information of the administered dose is sent to the Margin Makeras input and used to update the model.

Also shown is a BGM 30 which has means 34 for inserting test strips 52containing a sample of blood, for analysis by the BGM 30 by operatingthe buttons 36. The result of the analysis is stored and either shown inthe display 32 or transmitted to the master module 10 via thetransmitting means 12 for storage and input to the Margin Maker andpresentation on the larger display 11 or both. The patient can at thesame time be presented with the last couple of results over a timeperiod.

A test strip container 50 is provided for the safe keeping/storing oftest strips 52 in the space 55 and can be added/attached through lockingmeans 31. With this addition, a test strip 52 will always be available.

Further shown is a lancet device 40 removably attached to the BGM 30 orthe test strip container 50 by the locking means 31. This lancet device40 is used by first loading the lancet device through the grip 44 andthen pressing the button 42, which releases the lancet, piercing theskin, so that a blood sample can be obtained. With this inclusion, thelancet device 40 is always at hand. This has the advantage that a lancetdevice 40 is always available, for taking a blood sample and applying itto a test strip 52. The test strip 52 can then be inserted via the means34 into the BGM 30, which will start analysing the blood sample and,after completion of the analysis, will show the result in the display32. It is very useful to have the BGM 30 and the lancet device 40attached together in one compact unit, since a BGM 30 would not normallybe used without the lancet device 40.

In this way, information relevant to the Margin Maker and the individualdevices 20, 30 may automatically be received and transmitted between thefunctional master module 10 and the various devices 20, 30, which ensurean automatical update of the system.

Alternatively, the Margin Maker may only present choices to the userwhere there is a present and activated device for performing thesechoices (where applicable), e.g. a proposal of administering a certainamount of long acting insulin is only presented if a doser containinglong acting insulin is present, or a doser and a separate cartridgecontaining long acting insulin. The functional master module isresponsible for keeping track of which individual devices that arepresent and activated.

If the device containing the master module and/or the Margin Maker, thesystem may designate a new master module and a new Margin Maker eitherby transmitting and/or activating the relevant information in thedesignated device(s).

FIG. 6 shows another embodiment according to the invention. Two dosers610 are shown. The dosers 610 may contain different types of insulin(fast and slow acting). Also shown is a device 600 with a display 602,buttons for operation 601. In this particular embodiment the device 600is both the functional master module and the Margin Maker. The device600 is also provided with the functionality of a BGM and a slot 603 forreceiving test strips containing a blood sample.

The dosers 610 and the BGM functionality may, together with userspecified input e.g. a the device 600, provide the Margin Maker withrelevant input information to the model and/or expert system, so thatthe Margin Maker may present the resulting choices on the display 602.

FIG. 7 illustrates the general concept according to an embodiment of theinvention with respect to communication and exchange of information.Here the system consists of the portable units: a functional mastermodule, a doser, a BGM, an inhaler, the remote units: Remote Receiver,Physician/Expert Care-team and Stationary Unit and a CommunicationInterface between them.

The functional master module controls the information and data flowbetween itself and the other apparatuses and is collects relevant dataand information from all the other portable units and uses thisinformation to update the model accordingly. This data and informationcould e.g. be amount of medication, type of medication, body fluidconcentration, time stamp (date and time) and inventory logistics.Additionally, the patient can manually input information and datarelated to amount of food, measurement of physical activity in the waydescribed above.

This data and information can then be transmitted via a communicationinterface (which may be built into the master module) to external unitslike a database for data acquisition of the patient's data over time ora computer which the patient uses to be kept informed about histreatment. Alternatively, all the apparatuses could communicate to allthe others.

The information in the database can be accessed by a physician or anexpert care-team who could easily and quickly check for compliance toe.g. a diet or treatment course/progress. The physician or expertcare-team could send a notification (e.g. alert, warning and/or changeof regimen) to the patient if the data shows an inappropriate futuretreatment span. The patient could also be notified of a futureappointment in this way or receive guidance.

The system gives the patient a number of choices to a given situationbased on the model as described earlier. The patient could e.g. beinformed that the blood glucose level/concentration is quite high andthe patient could be presented with the choices of either exercising forgiven amount of time or administering a given amount of a given type ofmedication. The possibility of choices makes the patient feel more incontrol of the treatment and enhances the therapeutic value of thetreatment.

FIG. 8 illustrates two dosers and their communication paths. The dosersare identical for the typical patient, one doser containing fast actinginsulin, the other doser containing slow acting insulin. The doserscomprise a micro controller and memory. The dosers are capable ofholding information about the insulin type they contain. Thisinformation may either be obtained by the doser reading e.g. a bar codeon the cartridge or the information may be input from the patient. Thusthe features of the doser enable it to log information about the insulintreatment (insulin type size of the dose and time stamp).

One doser is equipped with a cap unit 73 which acts as a storagecontainer for an extra insulin cartridge, needles etc. The storagecontainer is capable of keeping track of the contents of the containerwhich enables it to keep the inventory list updated, as describedearlier in the present document.

The other doser is equipped with a cap unit 74 comprising a BGM, a microcontroller and memory. This enables the cap unit 74 to log informationabout the blood glucose concentration (with time stamp).

All the dosers 71, 72 and the cap units 73, 74 comprise an interfacewhich enables them to exchange data. In the present example thefunctional master device comprises the Margin Maker and is the BGM capunit 74, which, in addition to the local interface, comprises aninterface that enables it to communicate with external units throughstandard communication links (RS-232, Wireless local area network,phone, cellular phone, pager, satellite link, etc.). Through thesecommunication links, the patient's treatment data can be transferred tothe patient's own computer 80 or via e.g. the telephone system 75 to thepatient's electronic medical record on a central server 76. From here,the treatment data may be accessed by the patient e.g. from a web page,using a stationary computer 77, a laptop computer 78, a handheldcomputer 79, etc. Apart from the patient, the care-team can access thepatient's treatment data. The patient's master unit 74 can receive datafrom the central server 76, in addition to transmitting data.

This system has the advantage that the system can function on 3 levels:

If one of the patient's devices 71, 72, 73, 74 is isolated by means ofcommunication, it will log data.

When the patient's devices 71, 72, 73, 74 are within communicationdistance, the treatment data are transferred to the master unit 74,enabling it to supply the patient with an overview of his treatment andpresent choices as well as warnings or alarms if data shows that apotential dangerous situation may occur.

When the master device 74 is connected to the central server 76 throughstandard communication links, the treatment data is transferred to thepatient's electronic medical record. This enables an expert system onthe central server to notify the care-team if needed. The care-team maysend information back to the user or send help if needed.

Furthermore it is well known that due to the safety of the patient, thedevelopment of a medical device is a time consuming task. Using a localcommunication form between the patient's devices 71, 72, 73, 74 has theadvantage that only the master device 74 need to be redesigned to keepup with the continuous change in the standard communication links.

1. A system for assisting a diabetic subject in controlling bloodglucose levels, the system comprising: a. an insulin delivery unit; b. ablood glucose monitor; c. a master module that includes a processor thatis configured to receive a blood glucose value from the blood glucosemonitor and to run a model that predicts a future glucose value andcompares that value with a target value and then predict a dose ofinsulin that will result in an acceptable blood glucose level; and d.wherein the dose of insulin is transmitted to the insulin delivery unit.2. The system of claim 1, wherein the processor is configured to receiveother data from the subject.
 3. The system of claim 2 wherein the dataincludes information on size and type of meal to be ingested andanticipated duration and intensity of exercise.
 4. A system forassisting a diabetic subject in controling blood glucose levels, thesystem comprising: a. A first device; b. A blood glucose monitor; c. Amaster module that includes a processor that is configured to receive ablood glucose value from the sensor and to run a model that predicts aglucose value and compares that value with a target value and thenpredicts one or more courses of treatment that will result in anacceptable blood glucose level.
 5. The system of claim 4, wherein thefirst device receives a proposed course of treatment for the subject toimplement.
 6. The system of claim 5, wherein the first device is aninsulin delivery device.
 7. A tool for assisting a diabetic in achievingglycemic control, the tool comprising: a. A processor configured tomodel the human carbohydrate metabolism b. An input means for receivingdata about the subject c. a proposal generator for proposing one or morecourses of treatment that will result in a future blood glucose levelbeing in acceptable range, wherein the processor will only propose acourse of treatment if there is a corresponding device present that cancarry out the proposed course of treatment.
 8. The tool of claim 7,wherein the processor is configured to propose at least one course oftreatment includes administering a dose of insulin and wherein thatproposal is automatically transmitted to an insulin delivery device.